TEMPOCEM NE (MULTIPLE)

K970774 · Foremost Dental Mfg., Inc. · EMA · Jun 3, 1997 · Dental

Device Facts

• Record ID: K970774
• Device Name: TEMPOCEM NE (MULTIPLE)
• Applicant: Foremost Dental Mfg., Inc.
• Product Code: EMA · Dental
• Decision Date: Jun 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TempoCem N/E is a dental luting agent for the temporary cementation of provisional crowns and bridges. Federal law restricts this device to sale by, or on the order of a dentist, or other practitioner licensed by the law of the state in which he or she practices to use or order the use of this device.

Device Story

TempoCem N/E is a dental luting agent used by dentists for temporary cementation of provisional crowns and bridges. The device functions as a chemical adhesive to secure temporary restorations during the interim period before permanent cementation. It is applied by the clinician in a dental office setting. The output is a physical bond between the provisional restoration and the prepared tooth structure, facilitating patient comfort and protection of the prepared tooth during the treatment interval.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental luting agent (cement). Chemical composition and physical properties consistent with traditional temporary dental cements. Non-electronic, non-software device.

Indications for Use

Indicated for temporary cementation of provisional crowns and bridges in dental patients. Prescription use only.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 3 1997

Mr. D. Tim Wolf
Regulatory Affairs Manager
Foremost-Dental Mfg, Incorporated
242 - South Dean Street
Englewood, New Jersey 07631

Re: K970774
Trade Name: TempoCem N/E (Multiple)
Regulatory Class: II
Product Code: EMA
Dated: April 25, 1997
Received: April 29, 1997

Dear Mr. Wolf:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your

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Page 2 - Mr. Wolf

premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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K970774/A
Page ___ of ___

510(k) Number (if known): K970774

Device Name: TEMPOCEM N/E (Multiple)

Indications For Use:

TempoCem N/E is a dental luting agent for the temporary
cementation of provisional crowns and bridges.

Federal law restricts this device to sale by, or on the
order of a dentist, or other practitioner licensed by the
law of the state in which he or she practices to use or
order the use of this device.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CORH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K970774

Prescription Use: Yes
(Per 21 CFR 801 509)

Over-the-Counter Use: No
(Optional Format 1-2-96)

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